RecallDepth
Class II Terminated

Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd by: Torrent Pharmaceuticals Ltd., Indrad-382 721, Dist. Mehsana India, NDC 66993-463-30

Company
Torrent Pharma Inc.
Recall Initiated
July 22, 2013
Posted
August 7, 2013
Recall Number
D-830-2013
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
18,721 bottles
Firm Location
Kalamazoo, MI, United States

Reason for Recall

Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.

Distribution

Nationwide

Lot / Code Info

Lot #: BS392004A, Exp: 09/2014

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